Biogen, Elan seek okay for first-line Tysabri use in MS
Biogen Idec and Elan have filed for approval to sell their drug Tysabri
The application is for the drug to be used as a first-line treatment for multiple sclerosis, a move that could boost sales of the drug.
Demand for Tysabri has been curtailed due to concerns over its association with a potentially fatal infection known as progressive multifocal leukoencephalopathy, or PML, which is caused by the JC virus.
Now, however, there is a test for the virus to predict if patients are at risk of developing PML, opening the possibility that Tysabri could be used more widely and at an earlier stage of treatment.
Biogen and Elan said on Wednesday they had submitted applications to the U.S. Food and Drug Administration and the European Medicines Agency seeking approval for first-line use in patients with relapsing forms of multiple sclerosis (MS) who have tested negative for antibodies to the JC virus.
PML – Progressive multifocal leukoencephalopathy
The JC virus is generally harmless, but in people with weakened immune systems, such as those using immune system-suppressing drugs like Tysabri, it can lead to an increased chance of developing PML.
Tysabri is considered to be an effective treatment for Relapsing Remitting MS but fears over patients reacting to the JC virus caused the Tysabri to be pulled from the market. MS patients now consider the risk of PML is acceptable especially when the drug is considered to be so effective
Approval of the drug would give patients diagnosed with MS access to the drug much earlier. It still needs NICE approval if you live in the UK, another hurdle to be negotiated.
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Incidentally I’m on the ASCEND trial to investigate how well Tysabri can reduce the progression of SPMS. It is ‘double blind’ and I honestly have no idea if I’m on a placebo or tehereal thing. My balance has deteriorated, still just as stiff but things like spasms and pain are much less. Make up your own mind. To find out more about the trial click here.
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